Jim Doherty: Yes, of course, Barry. So the SHORELINE study, naturalistic study design, designed to follow patients within and evaluate both safety and tolerability’s around them and the need to repeat dosing for up to one year. The SHORELINE study has in the program first and foremost, it provides us with safety data for well over 1,000 patients now. Equally important, it provides some real-world evidence for how Zuranolone may be used if approved. So the SHORELINE is an important component in the NDA submission. So the data that completes the date is included in the NDA submission. The SHORELINE study also continues, so we have the newest cohort of SHORELINE, which is completing now. That cohort is a rollover cohort from the CORAL study. So that will provide some really additional interesting information for retreatment with Zuranolone?
Barry Greene: Yes. So — Ritu, so the data that you’ve seen today on SHORELINE is 1% multiple times. And it’s an essence what’s in the NDA filing, as Jim said, will be used largely from a safety database. We’ll have an update mid-year, which we think will be quite informative and when we get that update, we’ll let you know.
Ritu Baral: Great. And will that update be submitted to FDA at that time?
Barry Greene: There’s regular communications with FDA on data updates including SHORELINE.
Ritu Baral: Awesome. Thank you.
Barry Greene: Thanks, Ritu.
Operator: We’ll hear next from Yasmeen Rahimi from Piper Stanley.
Unidentified Participant: This is (ph) on for Yas. Thank you for taking our questions. So first one is, if you could provide a little bit of more color on the life cycle innovation study that you mentioned in the press release, related to design details and the timing of that study? And then second one is when should we expect to see the health economic data for the landscape and the next studies?
Barry Greene: Yes, . Thank you and please send our best to Yas. Jim, you want to take that?
Jim Doherty: Absolutely, Barry. So at the moment, we’re not providing any additional details on the lifecycle management study. So the (ph) data you’re referring to and there’s a lot of additional data for Zuranolone that is coming out in key publications and scientific conferences throughout 2023.
Helen Rubinstein : Thank you. I think we can move to the next question.
Operator: We’ll hear from Ami Fadia from Needham.
Eason Lee: Hi, good morning. This is Eason Lee on for Ami. Thanks for taking our question. So Biogen’s comments on its earnings call yesterday continue to be positive on the Zuranolone opportunity. Maybe could you provide some more details on how you all and Biogen are working together with regard to things like prepping the market, communicating with FDA, payers, et cetera? Thank you.
Barry Greene: Yes, Eason, thanks for the question. Yes, it was Biogen from the start, it’s been a phenomenal partner. And clearly with Chris Viehbacher coming on board, given his experience in leading larger , his leadership in pharma, as well as his experience of depression has really been an add to an already strong partnership. Together, we’re very bullish on the opportunity for Zuranolone help millions suffered from MDD and PPD. And we’re like minded in terms of the paradigm shift we’re looking to create in the treatment of depression. I’d say from a regulatory, development, commercialization, CMC, supply chain perspective, we’re step in step in how we’re working in the U.S. and it’s a 50-50 in the U.S. So we’re well prepared together, if approved to launch their own.
Operator: We’ll move next to Jay Olson from Oppenheimer.
Jay Olson: Hello? Hey, congrats on the progress and thank you for the update. Can you remind us what level of DEA scheduling you’re expecting to receive for Zuranolone and how the scheduling will impact the launch of the drug and physician and patient perception in Zuranolone? Thank you.
